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Calin Enea Popa

Senior Clinical Research Consultant, Pharmaceuticals

Hi, I'm Calin Enea Popa. Welcome to my profile!

Calin Enea Popa's Bio:

Calin Enea Popa is a Senior Clinical Research Consultant, holds a MD degree and a UK Professional Diploma in Management and has solid business, clinical research and medical care background. Using his  broad international experience Calin helped run successfully a full range of clinical trials (phases I to IV, biotechnology products, diagnostics, medical devices, pharmaceuticals, vaccines) in a large variety of therapeutic areas. Following are areas of expertise for Calin: ·         Clinical monitoring: pre-trial, initiation, monitoring, and close-out visits and site management in compliance with ICH-GCP and regulations ·         Clinical science: medical and scientific guidance, study design, CRF and database design, sampled monitoring plan, medical and safety training and oversight, data review and interpretation, DMC management ·         Medical writing: IND, CTD, investigator’s brochure, study synopsis, protocol, study manual, subject information sheet/informed consent form, SAE narratives, clinical study report, manuscript, SOPs ·         Project management: planning and implementation of all stages of global clinical trials from protocol development to clinical study report, selection and management of CROs and other vendors, coordination of sponsor resources ·         Proven working knowledge of ICH GCP and FDA / TPD / EMEA regulations, proven ability to cope both with scientific and organizational aspects of drugs and medical devices studies, high ability to understand complex medical concepts and to cope both with scientific and organizational aspects ·         Training: needs assessment, course development, presentation, exam writing, investigator meetings, accompanied field visits.   Calin Enea Popa is multilingual, fluent in French, English, German and Romanian and together with the Canadian and EU citizen, it makes travel around the world very easy . The therapeutic areas Calin worked are: ·          Cardiovascular (DVT, HTA, MI, ATS, CHD, CAD) ·         Dermatology (Atopic Dermatitis, Acne, Psoriasis) ·         Respiratory ( Asthma, Bronchitis, Pneumonia) ·         Endocrinology (DM I/II, Osteoporosis, Obesity) ·         Neurology (Alzheimer, Parkinson, Multiple Sclerosis) ·         Infectious Disease (HIV/AIDS, C. Difficile, Influenza) ·         Hematology ·         Oncology ( Melanoma, Bladder, Colorectal, Prostate, Leukemia, Lymphoma, Head & Neck, Gynecological, Lung CNS) ·         Medical Devices (Hepatitis, HIV,STD) ·         Ophtalmology ·         Pediatrics ·         +Gastroenterology

Calin Enea Popa's Experience:

  • Senior Clinical Research Consultant at PAREXEL

    July 2012 - March 2013

    Act as the main line of communication between the sponsor and the investigator. and maintain contact to marketing and sales department >Project coordination, planning and logistics, including overview of budget and timelines >Verifying that all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout >Responsible for the safety and proper conduct throughout the trial >Verifying that the investigator follows the approved protocol and all GCP procedures >Verifying that source data/documents and other trial records are accurate, complete, and maintained >Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs >Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator

  • Senior CRA Consultant at Advanced Clinical Research Services

    August 2007 - March 2012

    Act as the main line of communication between the sponsor and the investigator. and maintain contact to marketing and sales department >Project start-up, coordination, planning and logistics, including overview of budget and timelines >Verifying that all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout >Responsible for the safety and proper conduct throughout the trial >Verifying that the investigator follows the approved protocol and all GCP procedures >Verifying that source data/documents and other trial records are accurate, complete, and maintained >Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs >Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator

  • Senior CRA , Consultant at Amgen

    September 2008 - June 2009

    Act as the main line of communication between the sponsor and the investigator. and maintain contact to marketing and sales department >Project start-up, coordination, planning and logistics, including overview of budget and timelines >Verifying that all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout >Responsible for the safety and proper conduct throughout the trial >Verifying that the investigator follows the approved protocol and all GCP procedures >Verifying that source data/documents and other trial records are accurate, complete, and maintained >Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs >Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator

  • Senior CRA at INC Research

    September 2008 - October 2008

    >Act as the main line of communication between the sponsor and the investigator. and maintain contact to marketing and sales department >Project coordination, planning and logistics, including overview of budget and timelines >Verifying that all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout >Responsible for the safety and proper conduct throughout the trial >Verifying that the investigator follows the approved protocol and all GCP procedures >Verifying that source data/documents and other trial records are accurate, complete, and maintained >Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs >Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator

  • Senior CRA, Consultant at MedFocus

    September 2007 - September 2008

    >Act as the main line of communication between the sponsor and the investigator. and maintain contact to marketing and sales department >Project coordination, planning and logistics, including overview of budget and timelines >Verifying that all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout >Responsible for the safety and proper conduct throughout the trial >Verifying that the investigator follows the approved protocol and all GCP procedures >Verifying that source data/documents and other trial records are accurate, complete, and maintained >Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs >Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator

  • Senior CRA at Kendle

    2006 - June 2008

    >Act as the main line of communication between the sponsor and the investigator. and maintain contact to marketing and sales department >Project coordination, planning and logistics, including overview of budget and timelines >Verifying that all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout >Responsible for the safety and proper conduct throughout the trial >Verifying that the investigator follows the approved protocol and all GCP procedures >Verifying that source data/documents and other trial records are accurate, complete, and maintained >Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs >Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator

  • Senior Clinical Research Consultant at Bayer

    May 2013

    >Act as the main line of communication between the sponsor and the investigator. and maintain contact to marketing and sales department >Project start-up, coordination, planning and logistics, including overview of budget and timelines >Verifying that all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout >Responsible for the safety and proper conduct throughout the trial >Verifying that the investigator follows the approved protocol and all GCP procedures >Verifying that source data/documents and other trial records are accurate, complete, and maintained >Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs >Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator

  • Director of Global Clinical Development and Training at Advanced Clinical Research Services

    January 2009

    >Lead clinical and/or project teams. >Facilitated integration and communication of different study teams in order to fulfill study requirements >Built and trained teams with clear structure, rules, communication networks and conflict resolution practices. >Proactively influenced appropriate communication channels to articulate issues and achieve solutions. >Represented company at scientific & medical events, presenting clinical trials results. >Designed and reviewed protocols and final reports. >Participated in the human resources activities of the department where applicable (interviews, organizational development, evaluations, etc.). >Managed team members with a focus on supporting clinical development plans, corporate goals and individual development; establish goals and expectations >Ensured budgets, schedules, staffing and performance requirements are met. >Consulting in clinical trial design and implementation for Phase I-IV clinical studies. >Effectively facilitated the conduct of clinical trials and served as a resource to anticipate/resolve study conduct issues; >Recruited clinical investigative sites and negotiated study design and costs. >Monitored and managed adherence to national and international regulations and standards (ICH-GCP, FDA, Health Canada). >Reviewed adverse events and monitored safety. >Advised and monitored clinical aspects of US and international regulations in relation to clinical trials.

Calin Enea Popa's Education:

  • University of Montreal

    2006 – 2009
    M.Sc

  • University of Montreal

    2004 – 2006
    M.Sc
    Concentration: Biomedical Sciences

  • The Open University

    1997 – 2000
    Dipl. Mgmt.
    Concentration: Management

  • University of Medicine and Pharmacy ,,Iuliu Hatieganu" Cluj-Napoca

    1990 – 1996
    MD
    Concentration: General Medicine

  • Liceul Industial Iacob Mureasianu

    1983 – 1987
    BS
    Concentration: Mathematics & Physics



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